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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Not considered to be carcinogenic.
Key value for chemical safety assessment
Justification for classification or non-classification
There is no published information on the carcinogenicity of 'soybean oil, deodorizer distillates'. However, data is available for some of its constituents. Numerous carcinogenicity studies have been conducted on fatty acids and their salts (in particular oleic acid), a number of which are summarised in CIR (1987) and HERA (2002). Although differences compared to controls are observed in individual trials, these are generally reported to be within normal background variation. Several fatty acids (stearic acid; oleic acid and sodium palmitate) are Generally Recognised as Safe (GRAS) by the U.S. Food and Drug Administration (US FDA). Also, fatty acids as a group are permitted as direct food additives (HERA, 2002). Overall, fatty acids are not expected to be carcinogenic.
Glycerides with unbranched fatty acids of overall chain lengths in the range of C16-18, including C18-unsatd. revealed non-promoting effect on chemically induced mammary carcinogenesis in rats (Sylvester et al., 1986; Sundram et al., 1989). Glycerides with chain lengths ranging between C8-18, including C18-unsatd. were tested for carcinogenicity in rat (lifetime) at a dose representing 54% of the calories in diet (Vles and Gottenbos, 1972). There were no significant differences in lifespan, growth or food consumption between rats exposed to coconut oil, butter fat or soybean oil (hydrogenated or non-hydrogenated). Pathological changes were randomly distributed and, considering the total population, the number of tumour bearers was comparable between groups. Furthermore, the’glycerides’ (in the form of triglycerides such as olive oil, corn oil, sunflower oil, etc.) are also well known to be frequently employed as vehicles in toxicity studies following international testing guidelines (e.g. OECD) for the evaluation of repeated dose toxicity, carcinogenicity or reproductive/developmental toxicity of chemical substances, without any apparent adverse effects (CIR, 1997 and 2001b). They are also found toinhibit tumor promotion induced by standard promoters.
Tocopheryl acetate did not reveal any neoplastic effects when tested in a 2 year carcinogenicity trial in rats. Studies conducted in mice and rats suggest that tocopherols may in some cases have antitumourigenic properties. It is of note that tocopherols have often been used as a negative control in tumour promotion studies (Fiume, 2002).
No specific information could be found for sterols and sterol esters. However, given their long history of safe use in nutritional and cosmetic applications, carcinogenicity is not expected.
The carcinogenicity of squalene was evaluated in several skin painting studies in mice, as summarised in CIR (1982). Results were not consistent between studies; some indicated potential effects whereas others showed a protective role against carcinogens. Overall, based on its history of safe use in nutritional and cosmetic applications, squalene is not expected to be carcinogenic under normal and foreseeable use conditions.
Moreover, predictions for ‘fatty acids, C16-18 and C18-unsatd. and glycerides, C16-18 and C18-unsatd.’ (based on the main constituents) from the Danish QSAR database and Toxtree (v.1.6) model did not reveal any structural alerts for carcinogenicity.
Taken together, the above evidence suggests that soybean oil, deodorizer distillates do not have carcinogenic potentialand therefore do not not qualify for classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.
Additional information
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